Tissue Compression Device with Pressure Indicator

ABSTRACT

Tissue compression devices having pressure indicators and methods of using the same. The tissue compression devices provide feedback to a user with respect to the pressure being applied to selected tissue at a selected location such as a radial artery to assist the user in applying the desired amount of pressure to the tissue (such as the pressure needed to achieve hemostasis at an access site). The pressure indication may be provided by a ring indicator that moves between two configurations (e.g., a concave configuration and a convex configuration), a bellow chamber in a housing, a bladder located below a bladder window, etc.

RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C § 119 of U.S.Provisional Patent Application No. 61/895,940 titled TISSUE COMPRESSIONDEVICE WITH MULTI-CHAMBER BLADDER; U.S. Provisional Patent ApplicationNo. 61/895,953 titled TISSUE COMPRESSION DEVICE WITH PRESSURE INDICATOR;and U.S. Provisional Patent Application No. 61/895,944 titled TISSUECOMPRESSION DEVICE WITH TENSION LIMITING STRAP RETAINER—all of whichwere filed on Oct. 25, 2013 and are incorporated by reference herein.

Tissue compression devices having pressure indicators and methods ofusing the same are described herein.

BACKGROUND

The diagnosis and treatment of coronary artery disease is now oftenaccomplished using vascular delivery apparatus and techniques. Vasculardelivery may provide a variety of advantages because access to desiredlocations within a patient's body may be obtained without the need forgeneral anesthetic or more invasive surgical techniques. Access toperipheral arteries may be accomplished using a sheath having ahemostatic valve that is inserted into the peripheral artery. A catheteror other device can then be introduced into the vasculature of thepatient through that sheath to the desired location within thevasculature.

Access for these percutaneous coronary procedures may be obtainedthrough a radial artery of the patient. Access through a radial arterymay provide a number of advantages including improved patientmobilization and reduced cost. The use of a distal radial artery may,for example, allow for compression to be directly applied to the arteryto achieve and maintain hemostasis.

One potential complication with any arterial access is, however,achieving hemostasis during and/or after a procedure. Arterial bloodflow is pulsatile in nature and may present challenges to anypractitioner seeking to achieve hemostasis at an arterial access site.Upon completion of a procedure and after removal of a catheter or otherdevice located in the access site, pressure may be applied to the accesssite to achieve hemostasis and close the access site. Applying pressureat or at a point slightly upstream of the access site is one techniquethat may be used for achieving hemostasis. In many instances, continuouspressure may be needed to achieve hemostasis at the access site.Although it may be advantageous for the pressure to remain constant, insome instances a reduction in the level of applied pressure may beadvantageous after an initially higher level of pressure is applied tothe access site. Gradual reduction in the compression pressure may allowblood to flow through the artery of the access site to allow blood toreach tissue downstream from the access site. That blood flowing throughthe artery can, in some instances, improve clotting to achievehemostasis without continuing application of compression.

SUMMARY

Tissue compression devices having pressure indicators and methods ofusing the same are described herein.

The tissue compression devices described herein provide feedback to auser with respect to the pressure being applied to selected tissue at aselected location on a patient (e.g., pressure applied over a radialartery to assist the user in applying the desired amount of pressureneeded to achieve hemostasis at an access site). Although the tissuecompression devices and methods described herein may be used to applypressure to selected tissue at any selected location on a patient, thetissue compression devices may be particularly well-suited to applypressure to tissue that includes a radial artery or other blood vesselthat may, in one or more embodiments, be used as an access site for apercutaneous procedure.

In one or more embodiments, the tissue compression devices describedherein may include a ring indicator that moves between twoconfigurations, e.g., a concave configuration and a convexconfiguration, when a selected amount of pressure is being applied to anaccess site. In one or more embodiments, the ring indicator may includean indicator surface that is visible in only one of the configurations.Furthermore, in one or more embodiments, the ring indicator may providean audible indication as it moves between the concave and convexconfigurations described herein.

In addition to the ring indicators described in connection with one ormore illustrative embodiments of tissue compression devices describedherein, other pressure indicators may be used and are described hereinincluding, e.g., a pressure indicators that includes a bellows in ahousing, etc.

In one or more embodiments, the tissue compression devices describedherein may include a rotating mechanism (e.g., a dial) by which theamount of pressure applied to an access site by the bladder can beincrementally varied to provide a user with the ability to increase ordecrease pressure as needed.

In a first aspect, one or more embodiments of a tissue compressiondevice as described herein may include: a base comprising a bottomsurface and a top surface, wherein the base comprises a bladder orificeformed through the base from the bottom surface to the top surface;retention structure attached to the base, the retention structureconfigured to retain the base over a selected location, wherein thebottom surface of the base is configured to face selected tissue at theselected location and wherein the top surface of the base is configuredto face away from the selected tissue when the base is retained over theselected location; a bladder operably attached to the base, wherein alower surface of the bladder faces the selected tissue when theretention structure retains the base over the selected location, andwherein an upper surface of the bladder faces away from the lowersurface of the bladder; a ring indicator positioned above and in contactwith the upper surface of the bladder, wherein the ring indicator is ina concave configuration, wherein a force exerted by the upper surface ofthe bladder on the ring indicator moves the ring indicator from theconcave configuration to a convex configuration, and wherein an inneredge of the indicator ring is further away from the bottom surface ofthe base when the ring indicator is in the convex configuration thanwhen the ring indicator is in the concave configuration; wherein thetissue compression device defines a compression axis extending throughthe upper surface of the bladder, the bladder orifice in the base, andthe lower surface of the bladder when the base is retained over theselected location by the retention structure.

In one or more embodiments of the tissue compression devices describedherein, the ring indicator is configured to move from the concaveconfiguration to the convex configuration when fluid pressure in thebladder reaches a selected level.

In one or more embodiments of the tissue compression devices describedherein, the ring indicator comprises an indicator surface facing awayfrom the upper surface of the bladder and a contact surface facing andin contact with the upper surface of the bladder, wherein the indicatorsurface faces the compression axis when the ring indicator is in theconcave configuration and wherein the indicator surface faces away fromthe compression axis when the ring indicator is in the convexconfiguration. In one or more embodiments, the ring indicator comprisesan indicator color that contrasts with a color of the upper surface ofthe bladder.

In one or more embodiments of the tissue compression devices describedherein, the device further comprises a dial attached to the base, andwherein the ring indicator is attached to the dial.

In one or more embodiments of the tissue compression devices including adial as described herein, the device further includes a plurality ofdial posts extending from the top surface of the base, wherein theplurality of dial posts are arranged around a perimeter of the bladderorifice, wherein each post of the plurality of dial posts comprises aninner surface facing the bladder orifice and an outer surface facingaway from the bladder orifice; wherein the dial is mounted on theplurality of dial posts, the dial comprising a dial channel thatcomprises an opening facing the top surface of the base, an inner wallfacing the inner surfaces of the plurality of dial posts, and an outerwall facing the outer surfaces of the plurality of dial posts; matingfeatures on the inner surface of the plurality of dial posts and theinner wall of the dial channel that are configured to move the dialtowards the top surface of the base when the dial is rotated in a firstdirection about the compression axis and are also configured to move thedial away from the top surface of the base when rotated in a seconddirection about the compression axis. In one or more embodiments, themating features comprise raised ribs on the inner surfaces of theplurality of dial posts and recesses formed into the inner wall of thedial channel, wherein the raised ribs are located within the recesses.In one or more embodiments, the dial comprises a dial orifice, andwherein the upper surface of the bladder is visible through the dialorifice. In one or more embodiments, the ring indicator comprises anindicator surface facing away from the upper surface of the bladder anda contact surface facing and in contact with the upper surface of thebladder, wherein the indicator surface faces the compression axis whenthe ring indicator is in the concave configuration and wherein theindicator surface faces away from the compression axis when the ringindicator is in the convex configuration, and wherein the indicatorsurface of the ring indicator is visible to a viewer viewing the uppersurface of the bladder along the compression axis through the dialorifice when the ring indicator is in the concave configuration. In oneor more embodiments, the upper surface of the bladder forms a curvedsurface that bulges upward away from the top surface of the base whenthe dial compresses the upper surface of the bladder and/or wherein theupper surface of the bladder comprises a matte finish.

In one or more embodiments of the tissue compression devices including adial as described herein, the device further includes a stop memberextending from the top surface of the base, wherein the stop member islocated in the channel of the dial; a plurality of slots formed in theouter wall of the channel, wherein the stop member is configured toengage with the plurality of slots to prevent rotation of the dial aboutthe compression axis in the absence of a force acting to move the stopmember out of engagement with the plurality of stops; a stop memberrelease lever operably connected to the stop member, wherein the stopmember release lever is configured such that movement of the stop memberrelease lever moves the stop member out of engagement with the pluralityof slots in the outer wall of the dial channel such that the dial canrotate about the compression axis. In one or more embodiments, thedevice further comprises a second stop member extending from the topsurface of the base, wherein the second stop member is located in thechannel of the dial, wherein the second stop member is configured toengage with the plurality of slots to prevent rotation of the dial aboutthe compression axis in the absence of a force acting to move the secondstop member out of engagement with the plurality of stops; a second stopmember release lever operably connected to the second stop member,wherein the second stop member release lever is configured such thatmovement of the second stop member release lever moves the second stopmember out of engagement with the plurality of slots in the outer wallof the dial channel such that the dial can rotate about the compressionaxis.

In one or more embodiments of the tissue compression devices describedherein, a first portion of the bladder including the upper surface ofthe bladder is located above the top surface of the base, and wherein asecond portion of the bladder including the lower surface of the bladderis located between the bottom surface of the base and a limb on whichthe base is retained.

In one or more embodiments of the tissue compression devices describedherein, the bladder comprises an upper chamber positioned adjacent alower chamber, wherein the upper chamber is located above the topsurface of the base and the lower chamber is located below the bottomsurface of the base. In one or more embodiments, the bladder comprisesan opening between the upper chamber and the lower chamber, whereinfluid in the upper chamber can pass into or out of the lower chamberthrough the opening, and wherein inflation of the bladder moves the toplayer of the upper chamber away from the top surface of the base andalso moves the bottom layer of the lower chamber away from the bottomsurface of the base.

In one or more embodiments of the tissue compression devices including abladder having an upper and lower chamber as described herein, an outerperimeter of the upper chamber and an outer perimeter of the lowerchamber are larger than the bladder orifice as measured in a planetransverse to the compression axis.

In one or more embodiments of the tissue compression devices including abladder having an upper and lower chamber as described herein, an outerperimeter of the upper chamber has a different shape than a shape of anouter perimeter of the lower chamber when projected onto a planetransverse to the compression axis.

In one or more embodiments of the tissue compression devices including abladder having an upper and lower chamber as described herein, the upperchamber comprises a first upper chamber and wherein the bladder furthercomprises a second upper chamber located between the first upper chamberand the top surface of the base, wherein fluid within the first upperchamber passes through the second upper chamber when moving into thelower chamber.

In one or more embodiments of the tissue compression devices including abladder having an upper and lower chamber as described herein, the lowerchamber comprises a first lower chamber and wherein the bladder furthercomprises a second lower chamber located between the first lower chamberand the bottom surface of the base, wherein fluid within the first lowerchamber passes through the second lower chamber when moving into theupper chamber.

In one or more embodiments of the tissue compression devices describedherein, the bladder comprises a port in fluid communication with thebladder and configured to allow for fluid delivery into the bladder.

In one or more embodiments of the tissue compression devices describedherein, the bladder comprises a pump configured to deliver fluid intothe bladder.

In a second aspect, one or more embodiments of a method of monitoringpressure in a bladder of a tissue compression device as described hereinmay include restraining a tissue compression device over a selectedlocation, wherein the tissue compression device comprises: a bladdercomprising an upper surface located above and facing away from a topsurface of a base of the tissue compression device; a ring indicatorpositioned above and in contact with the upper surface of the bladder,wherein the upper surface of the bladder is located between the ringindicator and the top surface of the bladder, and wherein the ringindicator is in a concave configuration. The method may further includeincreasing fluid pressure within the bladder to cause the upper surfaceof the bladder to apply a force to the ring indicator sufficient to movethe ring indicator from the concave configuration to a convexconfiguration, wherein an inner edge of the indicator ring is furtheraway from the top surface of the base when the ring indicator is in theconvex configuration than when the ring indicator is in the concaveconfiguration.

In one or more embodiments of the methods as described herein, the ringindicator is configured to move from the concave configuration to theconvex configuration when the fluid pressure in the bladder reaches aselected level.

In one or more embodiments of the tissue compression devices describedherein, increasing fluid pressure within the bladder comprisesincreasing the volume of fluid within the bladder.

In one or more embodiments of the tissue compression devices describedherein, the tissue compression device comprises a dial attached to thebase, and wherein the ring indicator is attached to the dial, andfurther wherein increasing fluid pressure within the bladder comprisesrotating the dial in a first direction about an axis that extendsthrough the upper surface of the bladder to move the dial towards thetop surface of the base to compress the bladder. In one or moreembodiments, the method further comprises decreasing the fluid pressurewithin the bladder by rotating the dial in a second direction about theaxis to move the dial away from the top surface of the base.

In a third aspect, one or more embodiments of the tissue compressiondevices described herein may include a base and retention structureattached to the base, the retention structure configured to retain thebase over selected tissue at a selected location; a bladder operablyattached to the base, wherein a lower surface of the bladder faces theselected tissue when the retention structure retains the base over theselected location, and wherein an upper surface of the bladder facesaway from the lower surface of the bladder; a pressure indicatorpositioned on the upper surface of the bladder, wherein the pressureindicator comprises: a bellowed chamber comprising a top surface that isconfigured to move closer to the upper surface of the bladder whenpressure in the bladder is reduced and farther away from the uppersurface of the bladder when pressure in the bladder is increased, and anindicator housing, wherein the bellowed chamber is located in theindicator housing and visible through the indicator housing, wherein aposition of the top surface of the bellowed surface in the indicatorhousing is indicative of pressure in the bladder.

In one or more embodiments of the tissue compression devices describedherein, the indicator housing comprises visible indicia arrayed along aside surface, wherein the visible indicia is indicative of pressure inthe bladder.

In one or more embodiments of the tissue compression devices describedherein, the indicator housing is attached to the upper surface of thebladder.

In one or more embodiments of the tissue compression devices describedherein, the base comprises a bottom surface and a top surface, whereinthe base comprises a bladder orifice formed through the base from thebottom surface to the top surface, wherein the bellowed chamber and theindicator housing of the pressure indicator are located within aperimeter of the bladder orifice. In one or more embodiments, the devicedefines a compression axis extending through the upper surface of thebladder, the bladder orifice in the base, and the lower surface of thebladder when the base is retained over the selected location by theretention structure, and wherein the top surface of the bellowed chambermoves along the compression axis when pressure in the bladder is reducedor increased.

In a fourth aspect, one or more embodiments of a tissue compressiondevice as described herein may include a base and retention structureattached to the base, wherein the retention structure is configured toretain the base over selected tissue at a selected location, and whereinthe base comprises a bottom surface, a top surface, and a bladderorifice formed through the base from the bottom surface to the topsurface; a bladder operably attached to the base, wherein a lowersurface of the bladder faces the selected tissue when the retentionstructure retains the base over the selected location, and wherein anupper surface of the bladder faces away from the lower surface of thebladder; and a bladder window attached to the base, wherein the bladderwindow is located above the bladder orifice and the upper surface of thebladder, wherein the upper surface of the bladder and the bladder windoware configured such that a portion of the upper surface of the bladdercontacts the bladder window when pressure in the bladder reaches aselected pressure, wherein a larger portion of the upper surface of thebladder contacts the bladder window when pressure in the bladder isincreased, and wherein a smaller portion of the upper surface of thebladder contacts the bladder window when pressure in the bladder isdecreased.

In one or more embodiments of the tissue compression devices describedherein, the bladder window is located in a dial orifice of a dialattached to the base, wherein the dial is configured to rotate about acompression axis extending though the dial orifice, the bladder orifice,the upper surface of the bladder, and the lower surface of the bladder.In one or more embodiments, the device further comprises: a plurality ofdial posts extending from the top surface of the base, wherein theplurality of dial posts are arranged around a perimeter of the bladderorifice, wherein each post of the plurality of dial posts comprises aninner surface facing the bladder orifice and an outer surface facingaway from the bladder orifice; wherein the dial is mounted on theplurality of dial posts, the dial comprising a dial channel thatcomprises an opening facing the top surface of the base, an inner wallfacing the inner surfaces of the plurality of dial posts, and an outerwall facing the outer surfaces of the plurality of dial posts; matingfeatures on the inner surface of the plurality of dial posts and theinner wall of the dial channel that are configured to move the dialtowards the top surface of the base when the dial is rotated in a firstdirection about the compression axis and are also configured to move thedial away from the top surface of the base when rotated in a seconddirection about the compression axis. In one or more embodiments, themating features comprise raised ribs on the inner surfaces of theplurality of dial posts and recesses formed into the inner wall of thedial channel, wherein the raised ribs are located within the recesses.

In one or more embodiments of the tissue compression devices describedherein, the device further comprises visible indicia indicative of thesize of the portion of the upper surface of the bladder contacting thebladder window.

In one or more embodiments of the tissue compression devices describedherein, an upper surface of the bladder window comprises a surfaceconfigured to reduce specular reflection from the upper surface. In oneor more embodiments, the upper surface of the bladder window comprises amatte finish. In one or more embodiments, the upper surface of thebladder window comprises an anti-reflective coating. In one or moreembodiments, the upper surface of the bladder window comprises acurvature configured to reduce specular reflection experienced by a viewviewing the upper surface of the bladder window.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise. Thus, for example, reference to “a” or “the” component mayinclude one or more of the components and equivalents thereof known tothose skilled in the art. Further, the term “and/or” means one or all ofthe listed elements or a combination of any two or more of the listedelements.

It is noted that the term “comprises” and variations thereof do not havea limiting meaning where these terms appear in the accompanyingdescription. Moreover, “a,” “an,” “the,” “at least one,” and “one ormore” are used interchangeably herein.

The above summary is not intended to describe each embodiment or everyimplementation of the tissue compression devices or methods describedherein. Rather, a more complete understanding of the invention willbecome apparent and appreciated by reference to the followingDescription of Illustrative Embodiments and claims in view of theaccompanying figures of the drawing.

BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWING

FIG. 1 is a side view of one illustrative embodiment of a tissuecompression device as described herein.

FIG. 2 is a top view of the tissue compression device depicted in FIG.1, with the tension structure (e.g., the strap in this illustrativeembodiment) removed from the view for clarity.

FIG. 3 is a bottom view of the tissue compression device depicted inFIG. 1, with the tension structure and the bladder removed from the viewfor clarity.

FIG. 4 is a perspective view of the base of the tissue compressiondevice of FIG. 1 with the dial removed.

FIG. 5 is a cross-sectional view of the tissue compression devicedepicted in FIG. 3, with the cross-sectional view being taken along line5-5 in FIG. 3 (and with the bladder being removed for clarity).

FIG. 6 is a cross-sectional view of the dial of the illustrativeembodiment of a tissue compression device as depicted in FIG. 1, withthe cross-sectional view taken along line 6-6 in FIG. 1.

FIG. 7 is an enlarged cross-sectional view of the bladder located withinthe base of a tissue compression device of FIG. 5, with the ringindicator in a concave configuration.

FIG. 8 is an alternative view of the bladder depicted in FIG. 7, withthe bladder inflated and the ring indicator in its convex configuration.

FIG. 9A is a cross-sectional view of an alternative bladder that may beused in one or more embodiments of the tissue compression devicesdescribed herein.

FIG. 9B is a diagram depicting the size and shape of the outerperimeters of the bladder chambers and the bladder orifice depicted inFIG. 9A.

FIG. 9C is a cross-sectional view of another alternative bladder thatmay be used in one or more embodiments of the tissue compression devicesdescribed herein.

FIG. 9D is a diagram depicting the size and shape of the outerperimeters of the bladder chambers and the bladder orifice depicted inFIG. 9C.

FIG. 10A is a side view of another alternative multi-chamber bladderthat may be used in one or more embodiments of the tissue compressiondevices described herein.

FIG. 10B is a top view of the multi-chamber bladder depicted in FIG.10A.

FIG. 11 is a perspective view of one alternative embodiment of a tissuecompression device as described herein.

FIG. 12 is a top view of the base 420 of the tissue compression device410 of FIG. 11, with the bladder removed to allow viewing of the bladderorifice 428.

FIG. 13 is an exploded perspective view of the dial 460 of the tissuecompression device 410 of FIG. 11.

FIG. 14 is a top view of the dial 460 of the tissue compression device410 of FIG. 11.

FIG. 15 is a cross-sectional view of the dial 460 taken along line 15-15in FIG. 14.

FIG. 16 is a perspective view of the bladder 440 of tissue compressiondevice 410, with the bladder 440 removed from the tissue compressiondevice 410 and inflated.

FIG. 17 is an exploded view of components used to construct theillustrative embodiment of bladder 440 as depicted in, e.g., FIG. 16.

FIG. 18 is a cross-sectional view of another alternative embodiment of atissue compression device as described herein.

FIG. 19 is a cross-sectional view of one alternative pressure indicatorthat may be used in the tissue compression devices described herein.

FIG. 20 is a cross-sectional view of the pressure indicator of FIG. 19with the pressure in the bladder increased as compared to FIG. 19.

FIG. 21 is a perspective view of the pressure indicator of FIG. 19.

FIG. 22 is a perspective view of another alternative pressure indicatorthat may be used in the tissue pressure devices described herein.

FIG. 23 is a cross-sectional view of the pressure indicator of FIG. 22taken along line 23-23 in FIG. 22.

FIG. 24 is a cross-sectional view of the pressure indicator of FIG. 22with the pressure in the bladder increase as compared to FIG. 23.

FIG. 25 is a perspective view of one illustrative embodiment of a tissuecompression device including a strap retainer attached to the base ofthe device by an elastic member, the device further including a tensionindicator.

FIG. 26 is a cross-sectional view of the tissue compression device ofFIG. 25 taken along line 26-26 in FIG. 25.

FIG. 27 is an isolated view of another illustrative embodiment of aportion of a base of a tissue compression device including a strapretainer attached to the base by elastic member and a tension indicator,with the strap retainer being held in a retracted configuration.

FIG. 28 is a view of a portion of the base of a tissue compressiondevice as seen in FIG. 27, with the strap retainer being held in anextended configuration.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following description of illustrative embodiments, reference ismade to the accompanying figures of the drawing which form a parthereof, and in which are shown, by way of illustration, specificembodiments. It is to be understood that other embodiments may beutilized and structural changes may be made without departing from thescope of the present invention.

A side view of one illustrative embodiment of a tissue compressiondevice 10 as described herein is depicted in FIG. 1. The tissuecompression device 10 includes a base 20 and a retention structure 30attached to the base 20. In the depicted embodiment, the retentionstructure 30 is in the form of a strap that may be configured to wraparound a limb (e.g., an arm) on or in which tissue to be compressed bythe tissue compression device 10 is located. As discussed herein, in oneor more embodiments the tissue compression devices described herein maybe configured to compress an access site into a radial artery. Theretention structure 30 includes a first end 32 attached to one end ofthe base 20 and an opposite free end 34. The strap of retentionstructure 30 also includes, in the depicted embodiment, fasteners 36 and38 (e.g., hook and loop fasteners, interlocking mechanical fasteners,etc.) that are configured to allow the strap of retention structure 30to be attached to a slot 26 or other opening in the base 20. Thedepicted form of retention structure 30 is only one example of manydifferent straps, bands, belts, strips, etc. that could be used tosecure base 20 in a selected location on a limb and in the depictedfasteners 36 and 38 are only one form of fasteners that could be used(alternatives including, e.g., buckles, snaps, etc.).

In one or more embodiments, the retention structure 30 may beinextensible when secured around a limb or other anatomical structuresuch that increasing pressure in the bladder 40 of a tissue compressiondevice as described herein does not merely result in elongation orstretching of the retention structure 30 rather than increasing pressureon, e.g., an access site. In one or more alternative embodiments, suchas the illustrative embodiments depicted in FIGS. 23-27, the tissuecompression devices described herein may include a strap retainer thatis elastically attached to the base of the tissue compression device andwhich may, optionally, include a tension indicator that may, in one ormore embodiments, limit travel distance between the strap retainer andthe base of the tissue compression device.

The base 20 of the tissue compression device 10 includes a bottomsurface 22 and a top surface 24. The bottom surface 22 of the base 20 isconfigured to face a limb when retained thereon by the retentionstructure 30. The top surface 24 of the base 20 faces away from the limbon which the tissue compression device 10 is located. Other features ofthe base 20 of the tissue compression device 10 will be described inmore detail with respect to the following figures.

Also depicted in connection with the illustrative embodiment of FIG. 1is a bladder 40, although in the view of FIG. 1 only a portion of thebladder 40 is visible. In particular, the lower surface 42 of thebladder 40 is seen in FIG. 1. Inflation of the bladder 40 will, in oneor more embodiments, tend to move the lower surface 42 of the bladder 40away from the bottom surface 22 of the base 20. When the base 20 isrestrained on a limb by, e.g., the retention structure 30, inflation ofthe bladder 40 will force the lower surface 42 of the bladder 40 againstthe skin of the patient and, thereby, provide compression of selectedtissue (e.g., tissue at an access site, etc.) in contact with the lowersurface 42 of the bladder 40. That compression, when applied at anaccess site can, in one or more embodiments, provide hemostasis.

Another feature depicted in connection with the illustrative embodimentof tissue compression device 10 is a pump 50 that is fluidly connectedto the bladder 40 through a channel 52. In one or more embodiments, arelease valve 54 may be provided to allow for deflation of the bladder40. Although depicted as being located within the channel 52, in one ormore alternative embodiments the release valve 54 may be providedelsewhere in the tissue compression device 10.

As described herein, the volume of the bladder 40 may be increased(e.g., inflated) to increase pressure exerted on a selected location ona patient. Pump 50 is only one example of a fluid delivery device thatcan be used to deliver fluid to the bladder 40. Pumps used to deliverfluid to bladders in tissue compression devices described herein maytake many different forms, only one of which is depicted in connectionwith the embodiment of tissue compression device 10 depicted in FIG. 1.

Although the illustrative embodiment of tissue compression device 10includes a fluid delivery device in the form of a pump 50 that isintegrally formed with the bladder 40, in one or more alternativeembodiments, fluid may be delivered to the bladder 40 using any suitablefluid delivery device. For example, the volume of fluid in the bladder40 may be increased (or, in some instances, decreased) using a syringeinserted into a port provided in the bladder 40. In one or more otherembodiments, the bladder 40 may be provided with a fixed volume of afluid (e.g., air, saline, etc.) with changes in the compression forcebeing provided to a patient using the dial 60 as will be describedfurther herein. In other words, the tissue compression devices describedherein may or may not include a pump or other fluid delivery device toinflate or otherwise deliver fluid into the bladder 40.

Whether or not the bladders of tissue compression devices describedherein are inflated or have a fixed volume, dial 60, which is attachedto the base 20 above the top surface 24, may be used to increase and/ordecrease the amount of compression delivered by the tissue compressiondevice 10 described herein. In particular, the dial 60 may be rotatedabout a compression axis 12 to increase or decrease the compressionprovided by the bladder 40. Specific details with respect to themechanism by which rotation of dial 60 may be used to increase ordecrease compression will be described further herein.

FIG. 2 is a top view of tissue compression device 10 as depicted in FIG.1 with the retention structure (e.g., strap) 30 removed for clarity.Only the top surface 24 of the base 20 is visible in FIG. 2, although anadditional feature more clearly seen in FIG. 3 is the opening 27 intoslot 26. That opening 27 allows a strap to slide into the slot 26through the opening 27 during placement of the tissue compression device10. As a result, the opening 27 may simplify attachment of the strap ofretention structure 30 because the end of the strap need not be threadedthrough a hole in the base 20 in order to secure it.

Among the other features depicted in FIG. 2 are the dial orifice 61which is an opening through the dial 60. The dial orifice 61 provides,in one or more embodiments, visible access to the upper surface 44 ofthe bladder 40. The upper surface 44 of the bladder 40 faces away fromthe lower surface 42 of the bladder 40. Also visible within the dialorifice 61 in the depicted embodiment of tissue compression device 10 isthe ring indicator 70 with its inner edge 72 being located closest tothe compression axis 12. The ring indicator 70, as will be described inmore detail below, can operate to provide an indication regarding thelevel of compression provided by the tissue compression device 10.Additional features depicted in FIG. 2 include stop member releaselevers 80 which, as will be described in more detail below, can be usedto release the dial 60 for rotation about compression axis 12.

FIG. 3 is a view of the bottom surface 22 of the base 20 in which thebladder 40 has been removed from the base 20 to expose additionalfeatures of the tissue compression device as described herein. Among thefeatures seen in FIG. 3 are the compression axis 12, bottom surface 22of the base 20, and the bladder orifice 28 which is provided in the base20. In one or more embodiments, the bladder orifice 28 is formed throughthe base 20 from the bottom surface 22 to the top surface 24 and, aswill be described further herein, the bladder orifice 28 can, in one ormore embodiments, be used to retain the bladder 40 in engagement withthe tissue compression device 10.

As can be seen by the combination of FIGS. 1-3, the compression axis 12defined by the illustrative embodiment of tissue compression device 10extends through the upper surface 44 of the bladder 40, the bladderorifice 28 in the base 20 and the lower surface 42 of the bladder 40when the base 20 is retained over selected tissue (on, e.g., a limb) bythe retention structure 30.

Another feature that can be seen with reference to the view in FIG. 3 ofthe illustrative embodiment of tissue compression device 10 are the stopmember release lever relief openings 82 that may be provided in the base20 to allow movement of the stop member release levers 80 towards thecompression axis 12. Movement of the stop member release levers 80 may,as will be described further herein, be used to allow rotation of thedial 60 about the compression axis 12 to provide for increases ordecreases in the compression provided by the tissue compression devicesdescribed herein.

Operation of the dial 60 on the base 20 of the tissue compression device10 in the illustrative embodiment of tissue compression device 10 asdepicted in FIGS. 1-3 will now be described with reference to FIGS. 4-6.In particular, FIG. 4 is a perspective view of the base 20 of theillustrative embodiment of a tissue compression device 10 with thebladder 40, dial 60, and retention structure 30 removed from the base20. FIG. 5 is a cross-sectional view of the base 20 of the illustrativeembodiment of tissue compression device 10 taken along line 5-5 in FIG.3. FIG. 6 is a cross-sectional view of the dial 60 removed from theremainder of the tissue compression device 10 (with the view being takenalong line 6-6 in FIG. 1).

As seen in the other figures described above, the base 20 includes a topsurface 24. Other features seen in the views of FIGS. 1-3 include, forexample, the stop member release levers 80 along with one of the stopmember release lever relief openings 82.

Among the features are not seen in the previously described figures arethe stop members 81 that are operably connected to the stop memberrelease levers 80. Movement of each of the stop member release levers 80inwardly toward the compression axis 12 moves the connected stop member81 inwardly toward the compression axis 12. As described in more detailbelow, inward movement of the stop members 81 allows for rotation of thedial 60 about the compression axis 12.

Other features not seen in the views of FIGS. 1-3 include the dial posts62 that extend from the top surface 24 of the base 20. In one or moreembodiments the dial posts 62 are arranged around a perimeter of thebladder orifice 28 formed through the base 20. In the depictedembodiment, four dial posts 62 are depicted, although any number of dialposts 62 could be provided so long as they function to retain the dial60 on the tissue compression device 10 and provide for its rotationabout the compression axis 12. In one or more embodiments, each of thestop members 81 may be located between a pair of dial posts 62. Such anarrangement may, in one or more embodiments, provide additional supportand control for proper operation of the stop members 81 with respect tothe dial 60 of the tissue compression device 10.

The dial 60 includes a dial channel 65 that includes an opening facingthe top surface 24 of the base 20, with the dial posts 62 being locatedin the dial channel 65. The dial channel 65 includes an inner wallfacing the inner surfaces 64 of the dial posts 62 and an outer wall 84facing the outer surfaces 68 of the dial posts 62.

The dial posts 62 may, in one or more embodiments such as the depictedembodiment, include raised ribs 63 that extend from the inner surfaces64 of the dial posts 62. The raised ribs 63 may be arranged in a helicalmanner on the inner surfaces 64 of the dial posts 62. Further, theraised ribs 63 may fit within the recesses 66 formed into the inner wall67 of the dial channel 65. The raised ribs 63 and the recesses 66cooperate and are configured to move the dial 60 towards the top surface24 of the base 20 when the dial 60 is rotated in a first direction aboutthe compression axis 12.

Movement of the dial 60 towards the top surface 24 of the base 20 may,as described herein, result in an increase in pressure within thebladder 40. The pressure within the bladder 40 increases because thedial 60 compresses the portion of the bladder located between the dial60 and the top surface 24 of the base 20. In one or more embodiments,movement of the dial 60 towards the top surface 24 of the base 20 movesthe bottom surface 69 of the dial 60 (see, e.g., FIGS. 5, 7 and 8)towards the top surface 24 of the base 20.

As the bottom surface 69 moves towards the top surface 24 of the base20, the bottom surface 69 presses against the upper surface 44 of thebladder 40 to compress the bladder 40 between the bottom surface 69 ofthe dial 60 and the top surface 24 of the base 20. In embodiments thatinclude features such as, e.g., an indicator ring 70 at or near thebottom surface 69 of the dial 60, those features (such as the indicatorring 70) may also act on the upper surface 44 of the bladder 40 tocompress the bladder 40 as the dial 60 moves towards the upper surface24 of the base 20.

As the bladder 40 is compressed between the bottom surface 69 of thedial and the top surface 24 of the base 20 (and other features such as,e.g., the indicator ring 70), the upper surface 44 of the bladder 40may, in one or more embodiments, conform to the shape of the bottomsurface 69 of the dial 60 (and other features such as, e.g., theindicator ring 70)—particularly in those embodiments in which the uppersurface 44 of the bladder 40 is flexible. In one or more alternativeembodiments in which the upper surface 44 of the bladder 40 is lessflexible, the upper surface 44 may or may not conform to the featuresfound at or near the bottom of the dial 60. In the one or moreembodiments in which the upper surface 44 of the bladder 40 is flexible,however, the upper surface 44 of the bladder 40 may bulge or extendslightly upward into the dial opening 61 (and, if present, the openingformed within the indicator ring 70).

The raised ribs 63 and the recesses 66 may further be configured to movethe dial 60 away from the top surface 24 of the base 20 when the dial 60is rotated in in an opposite direction about the compression axis 12.Movement of the dial 60 away from the top surface 24 of the base 20 may,as described herein result in a decrease in pressure within the bladder40. Pressure within the bladder 40 decreases as the dial 60 moves awayfrom the top surface 24 of the base 20 because movement of the dial 60in that direction allows the portion of the bladder 40 located betweenthe dial 60 and the top surface 24 of the base 20 to expand in volume.In one or more embodiments, movement of the dial 60 away from the topsurface 24 of the base 20 moves the bottom surface 69 of the dial 60(see, e.g., FIGS. 5, 7 and 8) away from the top surface 24 of the base20.

The raised ribs 63 and recesses 66 are merely one example of matingfeatures that may be provided on the dial posts 62 and in the dialchannel 65 to provide for movement of the dial 60 towards and away fromthe top surface 24 of the base 20 when the dial 60 is rotated aboutcompression axis 12. Other complementary structures in or on the dialposts and in the dial channel may be used to move the dial 60 towards oraway from the top surface 24 of the base 20 to increase or decreasepressure within a bladder 40.

Rotation of the dial 60 about the compression axis may, in one or moreembodiments such as the illustrative embodiment depicted in FIGS. 1-6and/or 11-17, be limited or prevented by features also provided in thetissue compression devices described herein. In one or more embodiments,rotation of the dial 60 about the compression axis 12 may be limited inboth directions. In other words, the dial 60 may be prevented fromrotation in one direction that would move the dial 60 closer to the topsurface 24 of the base 20, as well as rotation in the opposite directionthat would move the dial away from the top surface 24 of the base 20.

In the illustrative embodiment of tissue compression device 10, thestructures that prevent rotation of the dial 60 include stop members 81which, as described above, are attached to stop member release levers80. Because the stop members 81 themselves are located within the dialchannel 65 when the tissue compression device 10 is assembled, a usermanipulates the stop member release levers 80 to move the stop members81 because the stop member release levers 80 are accessible. Asdescribed herein, movement of the stop members 81 allows for rotation ofthe dial 60 about the compression axis 12.

The stop members 81 prevent rotation of the dial 60 about compressionaxis 12 because the stop members 81 are configured to engage with slots84 that are provided in the outer wall 83 of the dial channel 65. Inparticular, the slots 84 are bounded on each side by raised portions 85.Each stop member 81 fits within one or more of the slots 84 and rotationof the dial 60 about axis 12 is limited and/or prevented by the raisedportions 85 found on each side of the slot 84. Although not depicted inFIG. 6, in one or more embodiments, the entire perimeter of the outerwall 83 of the dial channel 65 includes slots 84 bounded by raisedportions 85 so that, regardless of the particular rotational orientationof the dial 60 on the base 20, the stop members 81 may engage with atleast one slot 84 in the dial 62 control rotation of the dial 60 aboutcompression axis 12.

As discussed herein, the stop member release levers 80 are operablyconnected to the stop members 81. The stop member release levers 80 areconfigured such that movement of the stop member release lever 80 movesits associated stop member 81 out of engagement with, in the depictedembodiment, the slots 84 in the outer wall 83 of the dial channel 65. Ina design such as that depicted in the illustrative embodiment of FIGS.1-6, releasing only one of the stop members 81 from a slot 84 in theouter wall 83 of the dial channel 65 may not allow rotation of the dial60 about the compression axis 12. Rather, in a design such as thatdepicted in the illustrative embodiment of FIGS. 1-6, rotation of thedial 60 about the compression axis 12 may require that both of the stopmember release levers 80 be used to move their attached stop members 81out of engagement with slots 84 in the outer wall 83 of the dial channel65.

One potential advantage of such a design is that rotation of the dial 60about compression axis 12 may require the use of two hands, e.g., thethumb and a finger on one hand to move the stop member release levers 80and their associated stop members 81 out of engagement with the slots 84in the dial channel 65 and a second hand to rotate the dial 60 about thecompression axis 12. As a result, a patient wearing the tissuecompression device 10 on, e.g., an arm, would not typically be able torotate the dial 60 to adjust the compression provided by the device 10themselves because the hand of the limb on which the tissue compressiondevice 10 is located will not be able to reach the dial 60 and/or thestop member release levers 80. In other words, requiring compression ofthe stop member release levers using a thumb and finger to moveassociated stop members that limit or prevent rotation of dial 60 inboth directions about axis 12 may provide a tissue compression device inwhich the pressure cannot readily be adjusted by a patient wearing thedevice on an arm.

Although the stop member release levers 80, stop members 81, and theslots 84 with raised portions 85 on the outer wall 83 of the dialchannel provide one embodiment of structures that can be used to preventrotation of a dial on a tissue compression device as described herein,many other structures may also be used to prevent rotation in bothdirections about a compression axis as described herein.

The tissue compression devices described herein may, in one or moreembodiments, include a pressure indicator to provide visual feedbackregarding the amount of compression being delivered by the tissuecompression devices described herein. In one or more embodiments oftissue compression devices as described herein, such as the illustrativeembodiment depicted in FIGS. 1-6, the tissue compression device 10includes a pressure indicator in the form of a ring indicator 70 that isattached to the dial 60 so that it is positioned above and in contactwith the upper surface 44 of the bladder 40.

In the illustrative embodiment depicted in FIGS. 7-8, the ring indicator70 has a concave configuration and a convex configuration. In theconcave configuration as depicted in FIG. 7, an inner edge 72 of theindicator ring 70 is located closer to the top surface 24 of the base20. In its convex configuration as depicted in FIG. 8, the inner edge 72of the indicator ring 70 is located further away from the top surface 24of the base 20.

The indicator ring 70 moves between the concave configuration and theconvex configuration based on the force exerted on the indicator ring 70by the upper surface 44 of the bladder 40. The force exerted on theindicator ring 70 by the upper surface 44 of the bladder 40 is afunction of the fluid pressure within the bladder 40. Increasing thefluid pressure within the bladder 40 (and, as a result, increasing theforce exerted on the indicator ring 70 by the bladder 40) can beaccomplished by delivering additional fluid into the bladder 40 and/orby moving the dial 60 to compress the bladder 40 between the top surface24 of the base 20 and the dial 60 while holding the amount of fluidwithin the bladder 40 constant. Conversely, decreasing the fluidpressure within the bladder 40 (and, as a result, decreasing the forceexerted on the indicator ring 70 by the bladder 40) can be accomplishedby removing fluid from the bladder 40 and/or by moving the dial 60 awayfrom the top surface 24 of the base 20 to allow the bladder 40 expandwhile holding the amount of fluid within the bladder 40 constant.

As the bottom surface 69 moves towards the top surface 24 of the base 20during compression of the bladder 40 by the dial 60, the bottom surface69 presses against the upper surface 44 of the bladder 40 to compressthe bladder 40 between the bottom surface 69 of the dial 60 and the topsurface 24 of the base 20. In the embodiment depicted in FIGS. 7-8,indicator ring 70 at or near the bottom surface 69 of the dial 60 alsoacts on the upper surface 44 of the bladder 40 to compress the bladder40 as the dial 60 moves towards the upper surface 24 of the base 20.

As the bladder 40 is compressed between the bottom surface 69 (and theindicator ring 70) and the top surface 24 of the base 20, the uppersurface 44 of the bladder 40 may, in one or more embodiments, conform tothe shape of the bottom surface 69 of the dial 60 and the indicator ring70—particularly in those embodiments in which the upper surface 44 ofthe bladder 40 is flexible. In one or more alternative embodiments inwhich the upper surface 44 of the bladder 40 is less flexible, the uppersurface 44 may or may not conform to the features found at or near thebottom of the dial 60.

In the one or more embodiments in which the upper surface 44 of thebladder 40 is flexible, however, the upper surface 44 of the bladder 40may bulge or extend slightly upward away from the top surface 22 of thebase 20 and into the dial opening 61 and the opening formed within theinner edge 72 of the indicator ring 70. This bulging or curvature maytypically occur when, e.g., the dial 60 compresses the upper chamber 45of the bladder 40.

Specular reflection (e.g., glare) from the upper surface of a bladdermay, in one or more embodiments, prevent or limit viewing of the tissuelocated beneath the bladder. To limit specular reflection, one or morefeatures may be provided in the tissue compression devices describedherein. One optional feature that may be provided in one or moreembodiments of the tissue compression devices described herein isdepicted in connection with FIG. 8. In particular, the bulge orcurvature of the upper surface 44 of the bladder 40 within the openingformed by the inner edge 72 of the indicator ring 70 (or the dialorifice 61 in the dial 60 in those embodiments in which an indicatorring is not provided) may, in one or more embodiments, provide anadvantage in that specular reflection from the upper surface 44 of thebladder 40 may be reduced because of the curvature of that surface.

In one or more alternative embodiments, the upper surface 44 of thebladder 40 may be provided with a matte finish, anti-reflective coating,etc. that is configured to reduce specular reflection from the uppersurface 44 of the bladder 40. In one or more embodiments, any mattefinish, anti-reflective coating, etc. provided on the upper surface 44of the bladder 40 may reduce specular reflection from the upper surface44 of the bladder of visible light by 50% or more (when the uppersurface 44 of the bladder 40 is provided in a planar or flatconfiguration). Any such matte finish, anti-reflective coating, etc.should, however, be selected such that viewing of the tissue beneath thebladder 40 is not unduly hindered.

In one or more embodiments, the ring indicator 70 can be described as abi-stable structure in which the ring indicator 70 will only be found ineither the convex or concave configurations (in the absence of any forcethat would constrain it in between those configurations).

In one or more of the bi-stable embodiments, the ring indicator 70 isconfigured to move from the concave configuration to the convexconfiguration when the force exerted by the bladder 40 on the ringindicator 70 reaches (or exceeds) a selected force. The selected forceexerted by the bladder 40 on the ring indicator 70 may, in one or moreembodiments, be correlated to the compression force being delivered bythe lower surface 42 of the bladder 40 at a selected location on apatient.

Referring now to FIGS. 7-8, enlarged views of a portion of the base 20including the bladder orifice 28, a bladder 40 retained therein, anddial 60 with ring indicator 70 are provided to more completely describeoperation of the dial 60 and ring indicator 70 in connection with thetissue compression devices described herein. The ring indicator 70 isdepicted in its concave configuration in FIG. 7 and in its convexconfiguration in FIG. 8. As discussed herein, movement of the ringindicator 70 from the concave configuration to the convex configurationis caused by forces exerted on the ring indicator 70 by the uppersurface 44 of the bladder 40.

The ring indicator 70 includes an indicator surface 74 that faces awayfrom the upper surface 44 of the bladder 40 and a contact surface 76that faces the upper surface 44 of the bladder 40. Although the uppersurface 44 of the bladder 40 may not be in contact with the contactsurface 76 of the ring indicator 70 while the ring indicator 70 remainsin its concave configuration (see, e.g., FIG. 7), the upper surface 44of the bladder 40 will, in most embodiments, be in contact with thecontact surface 76 of the ring indicator 70 at some point during itsmovement from the concave configuration to the convex configuration(see, e.g., FIG. 8).

In one or more embodiments, the indicator surface 74 of the ringindicator 70 may be described as facing the compression axis 12 when thering indicator 70 is in its concave configuration (see, e.g., FIG. 7)and the indicator surface 74 of the ring indicator 70 may be describedas facing away from the compression axis 12 when the ring indicator 70is in its convex configuration.

In one or more embodiments, the indicator surface 74 of the ringindicator 70 may include one or more indicator colors that contrast withone or more of: the color of the upper surface 44 of the bladder 40, theinterior of the dial orifice 61, and the top surface 24 of the base 20.The one or more indicator colors used on the indicator surface 74 may beuseful for improving visibility of the indicator surface 74 of the ringindicator 70 when the ring indicator 70 is in its concave configuration.Potentially useful indicator colors may include but are not limited to,e.g., red, yellow, orange, green, a series of colors (such as, e.g., arainbow-like arrangement), etc.

In addition to providing visible indication of the status of the ringindicator 70, movement of the ring indicator 70 from the concaveconfiguration to the convex configuration may, in one or moreembodiments, also be accompanied by an audible indication. For example,the ring indicator 70 may make a sound such as a click, pop, etc. whenmoving from the concave configuration to the convex configuration toprovide an audible indication that the selected pressure level in thebladder has been reached.

As discussed herein, movement of the ring indicator 70 from its concaveconfiguration to its convex configuration occurs, in one or moreembodiments, when the pressure within the bladder 40 increases so thatthe bladder 40 exerts a force that meets or exceeds a selected force.The pressure within the bladder 40 is, in one or more embodiments,controlled by the volume of air or other fluid in the bladder 40 as wellas the position of the bladder 40 relative to the skin of a patient onwhich the tissue compression device containing the bladder 40 isretained (because lower surface 42 of the bladder 40 is in contact withthe patient's skin).

As described herein, the indicator surface 74 is visible to a userviewing the upper surface 44 of the bladder 40 through the dial orifice61 when the indicator ring 70 is in the concave configuration. Incontrast, the indicator surface 74 of the indicator ring 70 is obscuredby the dial 60 and, as a result, is not easily or readily viewable by auser viewing the upper surface 44 of the bladder 40 through the dialorifice when the ring indicator 70 is in its convex configuration. As aresult, the movement of indicator ring 70 from the concave configurationto the convex configuration in which the indicator surface 74 is noteasily or readily visible to a user viewing the upper surface 44 of thebladder 40 through the dial orifice 61 may provide, in one or moreembodiments, a visible indicator that the pressure within the bladder 40has reached or exceeded a selected level.

Once the pressure in the bladder 40 has reached the selected level sothat the indicator ring 70 moves from the concave configuration to theconvex configuration, a user may rotate the dial 60 to further adjustthe pressure within the bladder 40 by moving the dial 60 towards or awayfrom the upper surface 24 of the base 20. Moving the dial 60 towards oraway from the upper surface 24 of the base 20 may, in one or moreembodiments, result in compression of the upper chamber of the bladder40, with that compression changing the pressure applied to the patientby the tissue compression device. As described herein, movement of thedial 60 towards or away from the upper surface 24 of the base 20 may beaccomplished by mating features located on the dial posts 62 which arelocated in the dial channel 65 defined between an inner surface 64 andouter surface 83 as described above in connection with, e.g., FIGS. 4-6.

In one or more embodiments, the dial 60 and/or base 20 may includeindicia (e.g., alphanumeric characters, gradation marks, etc.) such thatthe relative rotational position of the dial 60 on the base 20 can bevisually discerned. That relative rotational position may be correlatedto selected changes in the compression of the bladder located in thetissue compression devices described herein. For example, rotation ofthe dial 60 about the axis 12 by a selected number of degrees (e.g., 15degrees, 20 degrees, 30 degrees, etc.) may correlate to a selectedvertical distance (along, e.g., axis 12) over which the dial 60 movestowards or away from the base 20. That selected vertical distance may,in one or more embodiments, correlate to a selected change in the fluidpressure in the bladder 40. As a result, rotation of the dial 60 aboutthe axis 12 by a selected number of degrees (which can be visuallydiscerned by a user when indicia are provided on the dial and/or base)may, in one or more embodiments, be correlated to a selected change inpressure in the bladder 40.

Although the indicator rings used in tissue compression devices asdescribed herein may, in one or more embodiments, be provided in theform of bi-stable devices as described above, in one or more alternativeembodiments, the ring indicators may not be the form of bi-stabledevices. For example, the indicator ring 70 may be constructed so thatit can move in a more continuous manner between the concaveconfiguration depicted in FIG. 7 and the convex configuration depictedin FIG. 8. In one or more of such embodiments, the inner edge 72 of theindicator ring 70 may be found at any position between the concaveconfiguration and the convex configuration depending on the fluidpressure found in the bladder 40.

As described above, the fluid pressure in the bladder 40 corresponds tothe force exerted on the indicator ring 70 by the upper surface 44 ofthe bladder 40. As a result, as the fluid pressure in the bladder 40increases, the location of the inner edge 72 of the indicator ring 70may move in a corresponding and continuous manner from its location inthe concave configuration to its location in the convex configuration asthe force exerted by the upper surface 44 of the bladder 40 on theindicator ring 70 increases. If the indicator surface 74 includes one ormore colors (in, e.g., a rainbow-like array, etc.), the color or colorsvisible (or at least predominantly visible) to a user through the dialopening 61 may change as the indicator ring 70 moves from the concaveconfiguration to the convex configuration.

In the one or more embodiments in which the indicator ring 70 is not abi-stable device, the indicator ring 70 may, however, be biased suchthat it takes the concave configuration as depicted in FIG. 7 in theabsence of any external forces applied to move the indicator ring out ofthat concave configuration.

The illustrative embodiment of bladder 40 depicted in, e.g., FIGS. 7-8,includes multiple chambers 45, 46, and 48. The upper chambers 45 and 46are located between the upper surface 24 of the base 20 and the ringindicator 70 along with the bottom of the dial 60. The lower chamber 48is positioned below the base 20. The two upper chambers 45 and 46 are influid communication with each other through an opening 47, while thechambers 46 and 48 are in fluid communication with each other through anopening 49. The upper chamber 45 includes a top layer that defines theupper surface 44 of the bladder 40, while the lower chamber 48 includesa bottom layer that defines the lower surface 42 of the bladder 40.

Although the depicted embodiment of bladder 40 includes two upperchambers above the upper surface 24 of the base 20 and only one lowerchamber below the bottom surface 22 of the base 20, alternativeembodiments of the tissue compression devices described herein thatinclude bladders with multiple chambers may include any number of upperchambers above the upper surface 24 of the base 20 (including, e.g., asfew as one upper chamber). Similarly, alternative embodiments of thetissue compression devices described herein may include bladders havingany number of lower chambers below the bottom surface 22 of the base 20(including, e.g., two or more lower chambers). Many different bladdersmay be used in the tissue compression devices described herein. Thebladder 40 depicted and described in connection with the illustrativeembodiment of tissue compression device 10 is only one example of apotentially useful bladder. Among the many alternative embodiments, onealternative embodiment of a bladder 140 that may be used in one or moreembodiments of tissue compression devices as described herein isdepicted in the cross-sectional view of FIG. 9A. The bladder 140 may, inone or more embodiments, be described as a bellows that includes anupper chamber 145 and a lower chamber 146 that are, in the depictedembodiment, aligned along axis 112 extending through the bladder orifice128 formed in the base 120.

The upper chamber 145 is located adjacent the lower chamber 146 andincludes a top layer 191 and a bottom layer 192. The top layer 191 isconnected to the bottom layer 192 about an outer perimeter 193 of theupper chamber 145. The outer perimeter 193 may, in one or moreembodiments, be formed by a fold in the material used to form the toplayer 191 and the bottom layer 192 of the upper chamber 145. The lowerchamber 146 includes a top layer 194 and a bottom layer 195. The toplayer 194 of the lower chamber 146 is attached to the bottom layer 195about an outer perimeter 196 of the lower chamber 146. The outerperimeter 196 may, in one or more embodiments, the formed by a fold inthe material used to form the top layer 194 and the bottom layer 195 ofthe lower chamber 146.

The bottom layer 192 of the upper chamber 145 is connected to the toplayer 194 of the lower chamber 146. In one or more embodiments, anopening 197 through which the upper chamber 145 is in fluidcommunication with the lower chamber 146 is provided at the junctionbetween the upper chamber 145 and the lower chamber 146. In one or moreembodiments, the bottom layer 192 of the upper chamber 145 and the toplayer 194 of the lower chamber 146 may be constructed of a continuouslayer of material such that the opening 197 is defined by a fold formedin that material. In one or more alternative embodiments, the bottomlayer 192 of the upper chamber 145 and the top layer 194 of the lowerchamber 146 may be attached to each other by one or more techniques suchas, e.g., welding, adhesives, etc.

Fluid (such as, e.g., gases or liquids) in the upper chamber 145 canpass into or out of the lower chamber 146 through the opening 197 formedbetween the upper chamber 145 and the lower chamber 146 as describedherein. In one or more embodiments, the opening 197 formed between theupper chamber 145 and the lower chamber 146 can be characterized asbeing smaller than the outer perimeters 193 and 196 of either of thebellows chambers 145 and 146 connected through the opening 197. The sizeof the opening 197 relative to the outer perimeters of the upper andlower chambers 145 and 146 is described in more detail in connectionwith FIG. 9B.

The bladder 140 is depicted as being located within the bladder orifice128 of a tissue compression device as described herein, with the upperchamber 145 located above the bladder orifice 128 and the lower chamber146 located below the bladder orifice 128. In particular, the upperchamber 145 is located above the top surface 124 of the base 120 suchthat the bottom layer 192 of the upper chamber faces the top surface 124of the base 120. The lower chamber 146 is located below the bottomsurface 124 of the base 120 such that the top layer 194 of the lowerchamber 146 faces the bottom surface 122 of the base 120.

Because the opening 197 is smaller than the outer perimeters 193 and 196of the upper chamber 145 and lower chamber 146 (respectively) and thebladder orifice 128, the bladder 140 may be retained within the bladderorifice 128 by mechanical interference between the layers of materialforming the upper and lower chambers and the upper and lower surfaces ofthe base 120 regardless of the volume of fluid within the bladder 140.As used herein with respect to bladders retained in the base of a tissuecompression device, “mechanical interference” means that one or more ofthe chambers in a bladder would need to be folded or otherwise deformedfrom its natural shape (i.e., the shape it takes in the absence offorces acting on it other than ambient air pressure and gravity) toremove the bladder from the bladder orifice in the base.

In the illustrative embodiment depicted in FIG. 9A, increasing thevolume of fluid in the bladder 140 may be described as moving the toplayer 191 of the upper chamber 145 away from the top surface 124 of thebase 120. Increasing the volume of fluid in the bladder 140 may also bedescribed as moving the bottom layer 195 of the lower chamber 146 awayfrom the bottom surface 122 of the base 120. The top layer 191 can becharacterized as forming the upper surface 44 of the bladder 40 depictedin connection with FIGS. 1-8, while the bottom layer 195 can becharacterized as forming the lower surface 42 of the bladder 40 depictedin connection with FIGS. 1-8.

FIG. 9B is a diagram in which the relative sizes and shapes of the outerperimeters of the upper and lower bladder chambers 145 and 146 as wellas the bladder orifice 128 provided in the base 120 and the opening 197between the upper and lower bladder chambers 145 and 146 are depicted.The diagram of FIG. 9B depicts the relative sizes of the outerperimeters 193 and 196, the bladder orifice 128, and the opening 197 asif each of those features is measured in a plane that is transverse tothe axis 112. In particular, the diagram depicted in FIG. 9B illustratesthat the outer perimeters 193 and 196 of the upper and lower chambersare of the same size and shape (which, in this illustrative embodimentmeans that the outer perimeters are both generally circular in shape).The bladder orifice 128, which is also depicted in FIG. 9B, has a sizethat is smaller than both of the outer perimeters 193 and 196. Inaddition, the size of the opening 197 between the upper and lowerbladder chambers 145 and 146 is depicted in FIG. 9B as being smallerthan the bladder orifice 128 and either of the outer perimeters 193 and196 of the upper and lower bladder chambers 145 and 146.

The bladder orifice 128, like the outer perimeters 193 and 196 and theopening 197, also has a generally circular shape, although the bladderorifice 128 may, in one or more alternative embodiments, have a shapethat is different than the shape of the outer perimeters of the upperand lower bladder chambers and/or the opening 197 between the upper andlower bladder chambers. For example, the bladder orifice 128 may have asquare, rectangular, triangular, etc. shape that is not the same as theshapes of the outer perimeters 193 and 196 of the upper and lowerchambers 145 and 146.

Another alternative embodiment of a multi-chamber bladder 240 that maybe used in connection with the tissue compression devices describedherein is depicted in FIG. 9C. The multi-chamber bladder 240 includes anupper chamber 245 and a lower chamber 246, with a lower surface 242 onthe bottom of the lower chamber 246 and an upper surface 244 on the topof the upper chamber 245. As a result, the lower chamber 246 and itslower surface 242 are both located below the bottom surface 222 of thebase 220 and the upper surface 244 on the upper chamber 245 are bothlocated above the top surface 224 of the base 220. The upper chamber 245and the lower chamber 246 are separated from each other by the bladderorifice 228 with the bladder 240 having a necked portion or area 297located within the bladder orifice 228 formed in the base 220. The upperchamber 245 and the lower chamber 246 are, in the depicted embodiment,aligned along axis 212 which passes through the bladder orifice 228.

In the multi-chamber bladder 140 depicted in FIG. 9A, the upper chamber145 is formed by sheets of material connected at the outer perimeter 193of the upper chamber 145 and the lower chamber 146 is formed by sheetsof material connected at the outer perimeter 196 of the lower chamber146. In addition, the layers of material forming the upper and lowerchambers 145 and 146 are connected to each other around the opening 197to form a multi-chamber bladder 140. In contrast, the multi-chamberbladder 240 depicted in FIG. 9C may, in one or more embodiments, beformed in the absence of the variety of separate layers of materialjoined together to form the chambers in multi-chamber bladders such asmulti-chamber bladder 140 depicted in FIG. 9A. For example, in one ormore embodiments, a multi-chamber bladder that may be used in the tissuecompression devices described herein such as, e.g., multi-chamberbladder 240 may be formed from a single layer of material that may beblow formed or otherwise manufactured to include fewer connectionsbetween separate layers.

The multi-chamber bladder 240 depicted in FIG. 9C is, however, like themulti-chamber bladders described elsewhere herein retained within thetissue compression device by mechanical interference between the upperchamber 245 and the lower chamber 246. In particular, both the upperchamber 245 and the lower chamber 246 have outer perimeters that arelarger than the bladder orifice 228. As a result, removal of the bladder240 from the bladder orifice 228 would require a user to manipulate thebladder 240 such that at least one of the outer perimeters of the upperchamber 245 and the lower chamber 246 are small enough to pass throughthe bladder orifice 228.

FIG. 9D is a diagram in which the relative sizes and shapes of the outerperimeters of the upper and lower bladder chambers 245 and 246, as wellas the bladder orifice 228 provided in the base 220 are depicted (whenthose features are viewed in the direction of the axis 212). Inparticular, the diagram depicted in FIG. 9D illustrates that the upperchamber has an outer perimeter 293 that is smaller than the outerperimeter 296 of the lower chamber. The bladder orifice 228, which isalso depicted in FIG. 9D, has a size that is smaller than the outerperimeter 293 of the upper chamber and is also smaller than the outerperimeter 296 of the lower chamber. The bladder orifice 228, like theouter perimeters 293 and 296, also has a generally circular shape,although the bladder orifice may, in one or more alternativeembodiments, have a shape that is different than the shape of the outerperimeters of the upper and lower bladder chambers as described herein.

Another illustrative embodiment of a multi-chamber bladder is depictedin a side view in FIG. 10A and a top view in FIG. 10B, where the topview is taken along the axis 312 seen in both figures. The multi-chamberbladder 340 includes an upper chamber 345 and a lower chamber 346. Theupper chamber 345 is separated from the lower chamber 346 by an opening397 that is configured to be located in a bladder orifice in the base ofa tissue compression device as described herein.

The multi-chamber bladder 340 is provided to illustrate yet anothervariation that may be provided in the multi-chamber bladders describedherein. The multi-chamber bladders described thus far herein may haveupper and lower chambers that have outer perimeters with the same shape,e.g., both the upper and lower chambers may have outer perimeters thatmay be circular or take some other shape (and which may, or may not, beof the same size). In contrast, the multi-chamber bladder 340 depictedin FIGS. 10A and 10B has an upper chamber 345 with an outer perimetershape that is different than the shape of the outer perimeter of thelower chamber 346.

The different shaped outer perimeters are best seen in the top view ofFIG. 10B, where the upper chamber 345 has an outer perimeter that isgenerally circular in shape, while the lower chamber 346 has an outerperimeter that is rectangular in shape. These shapes as depicted in FIG.10B are essentially projections of the outer perimeters of the upper andlower chambers 345 and 346 onto a plane that is transverse to the axis312. The combination of outer perimeter shapes depicted in connectionwith the illustrative embodiment of multi-chamber bladder 340 is onlyone example of the many varieties of shapes that could be provided. As aresult, the specific shapes depicted in FIGS. 10A and 10B should not beconstrued to be limiting in any way. For example, the shape of the outerperimeters of the upper and lower bladders may be reversed, i.e., theupper chamber may have a rectangular outer perimeter while the lowerchamber may have a generally circular perimeter. Furthermore, theexemplary shapes seen in connection with multi-chamber bladder 340 couldbe replaced by one or more of any suitable geometric shape (e.g.,triangle, square, oval, etc.). In still other embodiments, the outerperimeters of one or more chambers of the bladders used in tissuecompression devices described herein may have irregular shapes.

Another optional feature that may be provided in one or more embodimentsof the bladders used in the tissue compression devices described hereinis the port 351 connected to the bladder 340 by a channel 352. The port351 may be configured to connect to a fluid delivery device such as,e.g., a syringe, so that fluid can be delivered into or removed from thebladder 340 as described herein. In one or more embodiments, the port351 may be configured to allow only delivery of fluid into the bladder340 (e.g., a one-way valve may be provided to prevent escape of fluidfrom the bladder 340 through the port 351). Although the port 351 is, inthe depicted embodiment, connected to the bladder 340 by a channel 352,the port 351 may, in one or more alternative embodiments, be locateddirectly on the bladder 340 such that a channel 352 is not required.Further, although the port 351 and the channel 352 are, in the depictedembodiment, connected to the lower chamber 346 of the bladder 340, inone or more alternative embodiments, the port 351 may be configured todeliver fluid into and/or remove fluid from the upper chamber 345 of thebladder 340.

A perspective view of another illustrative embodiment of a tissuecompression device 410 is depicted in FIGS. 11-17. The tissuecompression device 410 includes a base 420 and a retention structure 430attached to the base 420. In the depicted embodiment, the retentionstructure 430 is in the form of a strap that may be configured to wraparound a limb (e.g., an arm) so that the tissue compression device 410is placed to compress selected tissue. In the depicted embodiment, theretention structure 430 includes a first end attached to one end of thebase 420 and an opposite free end configured to attach to the base 420as described elsewhere herein. In one or more embodiments, the retentionstructure 430 may be inextensible as described elsewhere herein.Furthermore, in one or more alternative embodiments, such as theillustrative embodiments depicted in FIGS. 23-27, the tissue compressiondevices described herein may include a strap retainer on the base 420that is rigidly or elastically attached to the base and which may,optionally, include a tension indicator as described herein.

The base 420 of the tissue compression device 400 and includes a bottomsurface 422 and a top surface 424. The bottom surface 422 of the base420 is configured to face a limb when retained thereon by the retentionstructure 430. The top surface 424 of the base 420 faces away from thelimb on which the tissue compression device 410 is located.

Also depicted in connection with the exploded perspective view of FIG.11 is a bladder 440. As with other illustrative embodiments describedherein, inflation of the bladder 440 will, in one or more embodiments,tend to move the lower surface of the bladder 440 away from the base420. When the base 420 is restrained on a limb by, e.g., the retentionstructure 430, inflation of the bladder will force the lower surface ofthe bladder 440 against the skin of a patient and, thereby, providecompression of selected tissue (e.g., tissue at an access site, etc.)that is in contact with the lower surface of the bladder 440. Thatcompression, when applied at an access site can, in one or moreembodiments, provide hemostasis.

In the depicted embodiment of tissue compression device 410, the bladder440 includes an upper chamber 445 and a lower chamber 446 has seen in,e.g., FIGS. 11 and 16. The bladder 440 also includes, in the depictedembodiment, a port 451 connected to the bladder 440 through a channel452. The port 451 may be configured to connect with a fluid deliverydevice such as, e.g., a syringe, etc. so that fluid can be deliveredinto and/or removed from the bladder 440 as described herein. Further,although the port 451 and the channel 452 are, in the depictedembodiment, connected to the lower chamber 446 of the bladder 440, inone or more alternative embodiments the port 451 may be configured todeliver fluid into and/or remove fluid from the upper chamber 445 of thebladder 440.

The bladder 440 in the depicted embodiment of tissue compression device410 is, in one or more embodiments, attached to the base 420 in a mannersimilar to that described above in connection with tissue compressiondevice 10. In particular, the upper chamber 445 of the bladder 440 maybe located above the top surface 424 of the base 420 while the lowerchamber 446 of the bladder 440 may be located below the bottom surface422 of the base 420 such that the lower chamber 446 is located betweenthe base 420 and the skin of a patient on which the tissue compressiondevice 410 is located. In such an arrangement, the connection betweenthe upper chamber 445 and the lower chamber 446 of the bladder 440 maybe located within a bladder orifice 428 formed in the base 420 (see,e.g., FIG. 12). As described herein, the bladder orifice 428 may, in oneor more embodiments, be formed through the base 420 from its bottomsurface to its top surface 424.

The depicted embodiment of tissue compression device 410 also includes adial 460 that is attached to the base 420 above the top surface 424.Whether or not the bladders of tissue compression devices describedherein are inflated using a separate device or have a fixed volume offluid located therein, the dial 460 may be used to increase and/ordecrease the amount of compression delivered by the tissue compressiondevice 410. In particular, the dial 460 may be rotated about acompression axis 412 to increase or decrease the compression provided bythe bladder 440. In one or more embodiments, the compression axis 412extends through the upper chamber 445 of the bladder 440, the bladderorifice 428 in the base 420 and the lower chamber 446 of the bladder 440when the base is retained over selected tissue (on, e.g., a limb) by theretention structure 430.

In the depicted embodiment of tissue compression device 410, the dial460 may be retained on the base 420 by dial posts 462 that extend upwardfrom the top surface 424 of the base 420. In one or more embodiments,the dial posts 462 are arranged around a perimeter of the bladderorifice 428 formed through the base 420. Any number, shape, and/or sizeof dial posts sufficient to retain the dial 460 on the base 420 and toprovide for its rotation as described herein is acceptable.

The depicted embodiment of tissue compression device 410 also includes astop member 481 that is operably connected to a stop member releaselever 480. Movement of the stop member release lever 480 inwardly towardthe compression axis 412 moves the connected stop member 481 inwardlytoward the compression axis 412. As described herein, inward movement ofthe stop member 481 allows for rotation of the dial 460 about thecompression axis 412.

In the depicted embodiment of tissue compression device 410, the dial460 includes a dial channel 465 with an opening facing the top surface424 of the base 420 when the dial 460 is located over the dial posts462. The dial posts 462 may include raised ribs that, in one or moreembodiments, may be arranged in a helical manner on the dial posts suchthat they cooperate with helical features 466 located within the dialchannel 465 of the dial 460. The raised ribs on the dial posts 462 andthe helical features 466 located within the dial channel 465 of the dial460 are configured to cooperate with each other such that rotation ofthe dial 460 about compression axis 412 in one direction moves the dial460 closer to the top surface 424 of the base 420, while rotation of thedial 460 in the opposite direction moves the dial 460 away from the topsurface 424 of the base 420.

As the dial 460 moves towards the top surface 424 of the base 120, thebottom surface 474 of the bladder window 470 located within a dialorifice 461 of the dial 460 presses against the upper surface of theupper chamber 445 of the bladder 440 to compress the upper chamber 445of the bladder 440 between the bottom surface 474 of the bladder window470 in the dial 460.

Another optional feature depicted in connection with the illustrativeembodiment of tissue compression device 410 is the window protrusion 476that extends away from the bottom surface 474 of the window 470. As aresult, the window protrusion 476 is located closer to the top surface424 of the base 420 than a portion of the bottom surface 474 of thebladder window 470 surrounding the window protrusion 476. The bladderwindow 470 itself may, in one or more embodiments, be clear ortranslucent to allow viewing of the bladder 440 located between thebladder window 470 and the top surface 424 of the base 420.

The window protrusion 476 may, in one or more embodiments, furtherinclude visible indicia such as a colorant, etc. that may identify thelocation of the bladder orifice 428 in the base 420. In one or moreembodiments, the portion of the bladder window 470 located within theboundaries of the window protrusion 476 may be clear while thesurrounding portion may be translucent to focus a user's attention onthe area directly beneath the compression axis 412 which, in one or moreembodiments, also extends through the window protrusion 476. Further, inone or more embodiments the window protrusion 476 may define a perimeteron the surface of a patient's skin over which blood may be allowed toflow when the tissue compression devices described herein are in properuse. For example, the flow of blood past the boundaries of the windowprotrusion 476 may indicate that pressure should be increased, while thepresence of no blood within the boundaries of the window protrusion 476may indicate that pressure is too high and should be decreased.

Rotation of the dial 460 about the compression axis 412 on the tissuecompression device 410 may, in one or more embodiments, be limited orprevented by features as described herein. In the depicted embodiment oftissue compression device 410, the structures that limit or preventrotation of the dial 460 include the stop member 481 which, as describedabove, is attached to the stop member release lever 480. The stop member481 itself is located within the dial channel 465 when the tissuecompression device 410 is assembled and is, therefore, inaccessible whenthe dial 460 is located on the base 420. As a result, a user manipulatesthe stop member release lever 480 to move the stop member 481 within thedial channel 465.

The stop member 481 prevents or limits rotation of the dial 460 aboutthe compression axis 412 because the stop member 481 is configured toengage with slots 484 that are provided in the outer wall 483 of thedial channel 465. In particular, the slots 484 are bounded on each sideby raised portions 485 as seen in, e.g., FIGS. 13 and 15. The stopmember 481 fits within one or more of the slots 484 and rotation of thedial 460 about compression axis 412 is limited and/or prevented by theraised portions 485 found on each side of the slots 484 as describedherein in connection with this and other illustrative embodiments of thetissue compression devices described herein.

In particular, the stop member release lever 480 is configured such thatmovement of the stop member release lever 480 towards the compressionaxis 412 moves its associated stop member 481 out of engagement with theslots 484 in the dial channel 465. In a design such as that depicted inthe illustrative embodiment of FIGS. 11-17, a user may be required toplace a thumb on the stop member release lever 480 or on the side of thebase 420 opposite the stop member release lever 480 and a finger on thefeature not occupied by the thumb, such that compression of the thumband finger towards each other across the dial 460 is required to movethe stop member release lever 480 towards the compression axis 412 torelease the dial 460 for rotation. This design also potentially providesthe advantage of requiring use of two hands, i.e., one hand to move thestop member release lever 480 and its associated stop member out ofengagement with slots 484 in the dial channel 465 while a second hand isused to rotate the dial 460 about the compression axis. As a result, apatient wearing the tissue compression device 410 on, e.g., an arm,would not typically be able to rotate the dial 460 to adjust thecompression provided by the device 410 themselves because the hand ofthe limb on which the tissue compression device 410 is located will notbe able to reach the dial 460 and/or the stop member release lever 480.As a result the tissue compression device 410 may be a device in whichpressure cannot be readily adjusted by a patient wearing the tissuecompression device on an arm.

The illustrative embodiment of tissue compression device 410 includes abladder 440 that is seen in FIG. 11 in the exploded view of the device410, depicted separately in FIG. 16 in an inflated state, and thecomponents used to construct this illustrative embodiment of a bladderthat may be used in tissue compression devices as described herein isdepicted in an exploded diagram in FIG. 17.

The upper chamber 445 is located adjacent the lower chamber 446 andincludes a top layer 491 and a bottom layer 492. The top layer 491 isconnected to the bottom layer 492 about an outer perimeter 493 of theupper chamber 445. The top layer 491 may be connected to the bottomlayer 492 along the outer perimeter 493 using any suitable technique orcombination of techniques (e.g., one or more of adhesives, thermalwelding, chemical welding, clamps, etc.). The outer perimeter 493 of theupper chamber 445 is identified in both the top layer 491 and the bottomlayer 492 in the exploded diagram of FIG. 17. The lower chamber 446includes a top layer 494 and a bottom layer 495. The top layer 494 ofthe lower chamber 446 is attached to the bottom layer 495 about an outerperimeter 496 of the lower chamber 446. The top layer 494 may beconnected to the bottom layer 495 along the outer perimeter 496 usingany suitable technique or combination of techniques (e.g., one or moreof adhesives, thermal welding, chemical welding, clamps, etc.). Theouter perimeter 496 of the lower chamber 446 is identified in both thetop layer 494 and the bottom layer 495 in the exploded diagram of FIG.17.

The bottom layer 492 of the upper chamber 445 is connected to the toplayer 494 of the lower chamber 446. In one or more embodiments, anopening 497 through which the upper chamber 445 is in fluidcommunication with the lower chamber 446 is provided at theconnection/junction between the upper chamber 445 and the lower chamber446. The opening 497 is provided in both the bottom layer 492 of theupper chamber 445 and the top layer 494 of the lower chamber 446. In oneor more embodiments, the bottom layer 492 of the upper chamber 445 andthe top layer 494 of the lower chamber 446 may be attached to each otherby one or more techniques such as, e.g., adhesives, thermal welding,chemical welding, clamps, etc.

Fluid (i.e., one or more gases and/or liquids) in the upper chamber 445can pass into or out of the lower chamber 446 through the opening 497formed between the upper chamber 445 and the lower chamber 446 asdescribed herein. In one or more embodiments, the opening 497 can becharacterized as being smaller than the outer perimeters 493 and 496 ofeither of the bellows chambers 445 and 446.

The bladder 440 spans the bladder orifice 428 of the tissue compressiondevice 410 as described herein, with the upper chamber 445 located abovethe bladder orifice 428 and the lower chamber 446 located below thebladder orifice 428. In particular, the upper chamber 445 is locatedabove the top surface 424 of the base 420 such that the bottom layer 492of the upper chamber 446 faces the top surface 424 of the base 420. Thelower chamber 446 is located below the bottom surface of the base 420such that the top layer 494 of the lower chamber 446 faces the bottomsurface of the base 420. In one or more embodiments, the bottom layer492 of the upper chamber 445 can be described as forming an upwardlydirected conical shape when the bladder 440 is inflated, while the toplayer 494 of the lower chamber 446 forms a downwardly directed conicalshape when the bladder 440 is inflated.

Another optional feature included in the illustrative embodiment oftissue compression device 410 is the addition of a seal line 498 alongwhich the bottom layer 492 of the upper chamber 445 is attached to thetop layer 494 of the lower chamber 446. The opening 497 is smaller thanthe seal line 498 such that the opening 497 is contained within andsurrounded by the seal line 498. In one or more embodiments, the sealline 498 may be fluid-tight such that the bottom layer 492 of the upperchamber 445 need not be attached to the top layer 494 of the lowerchamber 446 about the periphery of the opening 497.

The bladder and base of the tissue compression devices described hereinmay include complementary features designed to limit or prevent rotationof the bladder relative to the base about the compression axis. In oneor more embodiments, for example, the seal line 498 along which thebottom layer 492 of the upper chamber 445 is connected to the top layer494 of the lower chamber 446 may be asymmetric about at least one linewhen the seal line 498 is projected onto a plane transverse to thecompression axis 412 passing through upper chamber 445 and lower chamber446 of the bladder 440 and the bladder orifice 428 in the base 420. Inone or more embodiments, the seal line 498 may be described as forming akeyhole shape when projected onto a plane transverse to the compressionaxis 412, although seal lines forming shapes that have at least one linealong which they are asymmetric may be used in place of a keyhole shape,e.g., polygons, ovals, ellipses, irregular shapes, etc.

In one or more embodiments, the bladder orifice 428 in the compressiondevice body 420 of a tissue compression device as described herein mayhave a complementary shape that is also asymmetric about at least oneline when projected onto a plane transverse to the compression axis 412.In one or more embodiments, the bladder orifice 428 may be described asforming a keyhole shape when projected onto that plane. In one or morealternative embodiments the bladder orifice is in tissue compressiondevices as described herein that have at least one line along which theyare asymmetric when projected onto planes as described herein may beused in place of a keyhole shape, e.g., polygons, ovals, ellipses,irregular shapes, etc.

The exemplary keyhole shapes for both seal lines 498 and bladder orifice428 are both asymmetric about at least one line when projected onto aplane transverse to the compression axis 412. One potential advantage ofthe asymmetric shapes for both seal lines in bladders and bladderorifices as described herein is that rotation of the bladder about acompression axis when the bladder is assembled in the tissue compressiondevice may be limited or prevented because the asymmetry in the keyholeshapes prevents rotation of the bladder 440 about the compression axis412 due to mechanical interference between the bladder 440 and thebladder orifice 428 in the base 420. This may be useful where, forexample, a dial is rotated to adjust compression provided by the tissuecompression devices described herein because that dial rotation mayimpart rotational forces to the upper chamber of the bladder which couldin some instances cause corresponding undesired rotation of the bladder(which could, in turn, cause abrasion or twisting of the skin againstwhich the bladder 440 is compressed).

Another optional feature depicted in connection with the bladder 440used in the illustrative embodiment of tissue compression device 410 arethe shapes of the upper and lower chambers of the bladder 440. Inparticular, the outer perimeter 493 of the upper chamber 445 of thebladder 440 has, in the depicted embodiment, a circular shape whenprojected onto a plane transverse to the compression axis 412 (whichpasses through the upper surface 491, the bladder orifice 428, and thebottom surface 495 of the lower chamber 446). It should be understoodthat although described as having a circular shape, the upper chamber445 of the bladder 440 may also have a shape that approximates acircular shape such as, e.g., pentagons, hexagons, octagons, etc. Suchgenerally circular shapes fit well within the boundaries definedunderneath the dial 460.

While the upper chamber 445 of the bladder 440 has a generally circularshape, the lower chamber 446 of the bladder may be described as having anoncircular shape when projected onto the same plane as the upperchamber 445. In in the illustrative embodiment depicted in, e.g., FIGS.11, 15, and 16, the lower chamber 446 has a shape that is generallycircular along a portion of its perimeter and which also includes agenerally straight edge. Such a shape may, in one or more embodiments,provide for increased surface area coverage of the selected tissue to becompressed by a tissue compression device as described herein and, as aresult, may, in one or more embodiments, result in easier placement andbetter performance of the tissue compression devices as describedherein.

Another illustrative embodiment of a portion of a tissue compressiondevice as described herein is depicted in FIG. 18. In particular, FIG.18 includes a base 520 having a bottom surface 522 and a top surface524. A bladder 540 is located within and spans a bladder orifice 528 inthe base 520. The bladder 540 includes an upper chamber 545 locatedabove the top surface 524 of the base 520 and a lower chamber 546located below the bottom surface 522 of the base 520.

Also depicted in FIG. 18 are components designed to compress the upperchamber 545 of the bladder 540. In particular, the base 520 includesdial posts 564 that are configured to receive a rotating dial 560 whichrotates about compression axis 512. Rotation of the dial 560 aboutcompression axis 512 does not change the relative height of the dial 560relative to the base 520. Rather, rotation of the dial 560 about thecompression axis 512 moves the window 570 up or down along compressionaxis 512 as the dial 560 is rotated. In one or more embodiments, such asthat illustrated in FIG. 18, the conversion of rotational movement ofthe dial 562 linear movement of the window 570 is accomplished usingcomplementary threaded structures 562 on the dial 560 and 572 on thewindow 570.

The window 570 may, in one or more embodiments, include one or morefeatures designed to prevent its rotation relative to the compressionaxis 512 so that rotation of the dial 560 causes the window 570 totranslate up or down along compression axis 512. in one or moreembodiments, rotation of the window 570 about compression axis 512 maybe limited by the shape of the bottom surface 574 and the shape of topsurface 524 of the base 520. In particular, the curved complementaryshapes of those two services may, in one or more embodiments, limit orprevent rotation of the window 570 about compression axis 512. Otherstructures that prevent or limit rotation of the window 570 may be usedin place of and/or in addition to the complementary curved surfaces,e.g., slotted structures, etc. may be used to limit rotation of thewindow 570.

Movement of the window 570 changes the distance between the bottomsurface 574 of the window 570 and the upper surface 524 of the base 520,thus changing the allowable volume for the upper chamber 545 of thebladder 540 in between those two surfaces. Reducing that volume can beused as a way to increase pressure within the bladder 540 and,conversely, increasing the volume between the bottom surface 574 of thewindow 570 and the upper surface 524 of the base 520 may be used as away to decrease pressure within the bladder 540 as described herein inconnection with other embodiments of tissue compression devices.

In one or more embodiments of tissue compression devices as describedherein, it may be useful to provide some indication as to the pressurebeing delivered by the tissue compression devices. As discussed herein,the bi-stable ring indicators are only one illustrative embodiment of apressure indicator that may be used in the tissue compression devicesdescribed herein. One alternative embodiment of a pressure indicatorthat may be used in connection with the tissue compression devicesdescribed herein is depicted in FIGS. 19-21.

The pressure indicator 690 is in the form of a bellowed chamber 691located on the upper surface 644 of a bladder that may be used in atissue compression device as described herein. The interior of thebellowed chamber 691 is in fluid communication with the interior of thebladder through an opening 692 in the upper surface 644 of the bladder.The bellowed chamber 691 is, in the depicted embodiment, located withina housing 693. The housing 693 may also be attached to the upper surface644 of the bladder and may further include a vent 694. The vent 694 isused to allow for the escape of air from the housing 693 as the bellowedchamber 691 expands when pressure within the bladder increases. Thatexpansion is depicted in the changes between FIGS. 19 and 20, whereinthe bellowed chamber 691 occupies a larger volume of the housing 693 inFIG. 20.

In one or more embodiments, the housing 693 may be transparent ortranslucent and include indicia 695 to provide a visual reference withrespect to the amount of pressure within the bladder. As the bellowedchamber 691 increases in volume, its upper surface will be located at aheight that corresponds to a different level of the indicia 695. Becausethe housing 693 is transparent or translucent, the location of the uppersurface of the bellowed chamber 691 can be seen through the housing 693.

Although not depicted in FIGS. 19-21, the pressure indicator 690 may, inone or more embodiments, be located within a dial orifice on the uppersurface 644 of a bladder located within a tissue compression device asdescribed herein. In one or more embodiments, the pressure indicator 690may be aligned along the compression axis 612 formed within a tissuecompression device as described herein.

Another alternative embodiment of a pressure indicator that may be usedin connection with the tissue compression devices described herein isdepicted in FIGS. 22-24. In particular, a dial 760 is depicted in FIG.22 and includes a bladder window 790, with the bladder window beinglocated above the bladder orifice 728 formed in a base 720 as well asabove the upper surface 744 of a bladder 740. The bladder windowincludes indicia 795 which, in one or more embodiments, may be in theform of concentric circles provided on the bladder window 790. In one ormore embodiments, such as that depicted in, e.g., FIG. 22, the dial 760is configured for rotation about a compression axis 712 which is similarto the compression axes described elsewhere herein.

The dial 760 is, in the depicted embodiment, configured for rotationabout the compression axis 712 using dial posts 762 extending upwardlyfrom the upper surface 724 of a base 720 and into the dial channel 765as depicted in FIGS. 23-24. As with the dials described in theillustrative embodiments described above, the dial 760 may be rotatedtowards or away from the upper surface 724 of the base 720 to increaseor decrease pressure within the bladder 740.

The illustrative embodiment of the pressure indicator depicted in FIGS.22-24 provides an indication of the pressure being applied by thebladder 740 of the tissue compression device based on the amount of theupper surface 744 of the bladder 740 that is in contact with theunderside of the bladder window 790. The contact area between the uppersurface 744 of the bladder 740 and the bladder window 790 may beindicated in FIGS. 23-24 by the dimension C provided in each of thosefigures. In particular, the smaller contact area indicated by thesmaller dimension C in FIG. 23 may be indicative of a lower pressurewithin the bladder 740 as compared to the larger contact area indicatedby the larger dimension C in FIG. 24.

The indicia 795 provided on or in the bladder window 790 may be usefulin providing a visual indicator of the amount of contact between theupper surface 744 of the bladder 740 and the bladder window 790. Alarger portion of the upper surface 744 of the bladder 740 contacts thebladder window 790 when pressure in the bladder 740 is increased.Conversely, a smaller portion of the upper surface 744 of the bladder740 contacts the bladder window 790 when the pressure in the bladder 740is decreased. The indicia 795 may, in one or more embodiments, provide aconvenient way of visually determining the amount of increase ordecrease in the portion of the upper surface 744 of the bladder 740 thatis in contact with the bladder window 790 as pressure in the bladder ischanging. That visual determination can be made by noting the increaseor decrease in the number/amount of indicia 795 located within the areaof the bladder window 790 that is contacted by the upper surface 744 ofthe bladder 740.

Although the indicia 795 is depicted as being located on the bladderwindow 790 in the illustrative embodiment of FIGS. 22-24, in one or morealternative embodiments, indicia may be provided on the upper surface744 of the bladder 740 in addition to, or in place of the indicia on thebladder window 790. Indicia provided on the upper surface 744 of thebladder 740 may, in one or more embodiments, provide a convenient way ofvisually determining the amount of increase or decrease in the portionof the upper surface 744 of the bladder 740 that is in contact with thebladder window 790 as pressure in the bladder is changing. That visualdetermination can be made by noting the increase or decrease in thenumber/amount of indicia on the upper surface 744 of the bladder 740that are in contact with the bladder window 790.

In one or more alternative embodiments, the upper surface of the bladderwindow 790 may be provided with a matte finish, anti-reflective coating,etc. that is configured to reduce specular reflection from the uppersurface of the bladder window 790 (where the upper surface of thebladder window 790 is the surface facing away from the bladder 740). Inone or more embodiments, any matte finish, anti-reflective coating, etc.provided on the upper surface the bladder window 790 may reduce specularreflection from the upper surface of the bladder window of visible lightby 50% or more (when the upper surface of the bladder window 790 isprovided in a planar or flat configuration). In one or more alternativeembodiments, the bladder window 790 may be provided with some curvature(either concave or convex) to reduce specular reflection experienced bya viewer viewing the upper surface of the bladder window 790. Regardlessof the feature or features used to reduce specular reflection, any suchfeatures should not unduly hinder visibility of the tissue locatedbeneath the bladder 740.

Additional features that may be included in one or more embodiments ofthe tissue compression devices described herein are depicted inconnection with FIGS. 25-28. Those additional features may include astrap retainer that is elastically attached to the base of the tissuecompression device, as well as a tension indicator that may, in one ormore embodiments, limit the travel distance between the strap retainerand the base of the tissue compression devices as described herein.

The illustrative embodiment of tissue compression device 810 includes apressure apparatus 840 on a base 820 that is configured to be attachedto a patient using a strap 830 having a first end 832 attached to oneend 821 of the base 820. A strap retainer 801 is attached to theopposite end of the base 820 and includes a slot 826 or other openingconfigured to receive and retain the strap 830. Because the strap 830 isattached to opposite ends of the base 820, the strap 830 can be used toencircle a limb or other portion of a patient's anatomy to retain thetissue compression device 810 on the patient.

The strap 830 may, in one or more embodiments, include fasteners (e.g.,hook and loop fasteners, interlocking mechanical fasteners, buckles,snaps, etc.) that are configured to allow the strap 830 to form a loopfor attachment to the strap retainer 801. Alternatively, the strap 830and strapped retainer 801 may include features configured to form aconnection or attachment between the strap 830 and the strap retainer801. For example, the strap retainer 801 may be in the form of a buckle,the strap 830 and strap retainer 801 may include snaps or othercomplementary features that enable attachment of the strap 832 the strapretainer 801. In still other embodiments, the strap 830 and strapretainer 801 may include other complementary connection apparatus suchas, e.g., hook and loop fasteners, interlocking mechanical fasteners,etc.

In the depicted embodiment, the strap retainer 801 has a slot 826 thatincludes an optional opening 827 into the slot 826. The opening 827allows the strap 830 to slide into the slot 826 during placement of thetissue compression device 810. As a result, the opening 827 may simplifyattachment of the strap 830 to the strap retainer 801 because the freeend 834 of the strap 830 need not be threaded through a hole in thestrap retainer 801 in order to secure it.

When the strap 830 is attached to the strap retainer 801, the base 820and the strap 830 cooperate to retain the pressure apparatus 840 of thetissue compression device 810 over a selected location on a patient,e.g., an access site, etc. Although the depicted embodiment of tissuecompression device 810 includes a pressure apparatus 840 that may besimilar in construction to the pressure apparatus described in otherillustrative embodiments of tissue compression devices described herein,other forms of pressure apparatus may also be used in conjunction withtissue compression devices including elastically attached strapretainers as described herein.

In one or more embodiments, the strap 830 may be inextensible along itslength such that when the strap 830 is attached to the strap retainer801, the distance along the length of the strap 830 between the firstend 821 of the base 820 and the strap retainer 801 does not change astension along the strap 830 increases during normal use of the tissuecompression device 810.

As described herein, however, the strap retainer 801 is attached to oneend of the base 820 by an elastic member 802. As a result, the strapretainer 801 moves away from the base 820 in response to tension forcesapplied to the strap retainer 801 by the strap 830. In one or moreembodiments, the strap retainer 801 and elastic member 802 may bedescribed as being configured to draw the strap retainer 801 towards thebase 820 against any tension forces applied to the strap retainer 801by, e.g., the strap 830.

The elastic member 802 may take a variety of different forms, e.g.,elastic member 802 may be a woven and/or nonwoven elastic constructionsimilar to straps used on, e.g., clothing, luggage, etc. In one or morealternative embodiments, the elastic member 802 may be in the form of asolid elastic construction, e.g., the elastic member 802 may be in theform of a solid body of, e.g., an elastomeric polymer, rubber, latex,etc. In still other alternative embodiments, the elastic member 802 maybe in the form of a composite structure. Regardless of the specificconstruction of the elastic member 802, it may, in one or moreembodiments, be configured to provide a biasing force that draws thestrap retainer 801 towards the base 820 of the tissue compressiondevices described herein.

In addition to the elastic member, a tension indicator may also beprovided in one or more embodiments of the tissue compression devicesdescribed herein. The tension indicator 803 depicted in the illustrativeembodiments seen in FIGS. 25-28 may, in one or more embodiments, providefeedback to a user regarding the tension force exerted between the base820 and the strap retainer 801 by the elastic member 802. In thedepicted embodiment, the tension indicator 803 includes a fixed end 806attached to the strap retainer 801 and a traveling end 804 locateddistal from the fixed end 806 of the tension indicator 803. The tensionindicator 803 passes through a slot 805 in the base 820 and isconfigured to move through the slot 805 as the strap retainer 801 movestowards and away from the base 820. Although the depicted embodiment oftension indicator 803 moves through a slot 805 in the base 820, in oneor more alternative embodiments, the tension indicator 803 may not berequired to move through a slot. For example, the tension indicator maymerely move relative to the base of the tissue compression devicewithout being required to pass through a slot.

While the elastic member 802 is elastically extensible in response totension forces applied to the elastic member 802 as described herein,the tension indicator 803 may, in one or more embodiments, be in theform of an inextensible member (i.e., does not stretch or change inlength during normal use of the tissue compression devices describedherein).

In one or more embodiments, the tension indicator 803 may be in the formof a separate and discrete article from the elastic member 802. Thisseparate and discrete construction may be seen in, e.g., thecross-sectional view depicted in FIG. 26, where the elastic member 802and the tension indicator 803 are located next to each other but are notattached to each other except for their connection through the strapretainer 801 and/or the base 820.

The tension indicator 803 may, in one or more embodiments, providefeedback to a user regarding the tension force exerted between the base820 and the strap retainer 801 by the elastic member 802 in one or moreof a variety of ways. For example, in one or more embodiments, feedbackregarding the tension force exerted between the base 820 and the strapretainer 801 by the elastic member 802 may be indicated by the relativepositions between the strap retainer 801, the base 820 and the tensionindicator 803. In one or more embodiments, visible indicia that may beprovided on the base 820 and/or the tension indicator 803 to assist theuser in monitoring the tension force exerted between the base 820 andthe strap retainer 801 by the elastic member 802. In one or moreembodiments, both visible indicia and the relative positions describedherein may be used to provide feedback to user regarding the tensionforce.

The relative positions between the strap retainer 801, the base 820 andthe tension indicator 803 may, in one or more embodiments, be correlatedto a tension force applied by the elastic member 802 between the strapretainer 801 and the base 820. In particular, the correlation betweentension force and distance between the strap retainer 801 and base 820may be a function of the spring constant of the elastic member 802,i.e., the tension force supplied by the elastic member 802 increases asthe elastic member 802 is elongated and, conversely, the tension forcesupplied by the elastic member 802 decreases as the elastic member 802is allowed to retract or shorten its length.

In one or more embodiments, the tension indicators provided inconjunction with the tissue compression devices described herein may beconfigured to limit the travel distance over which the strap retainersmove relative to the bases of the tissue compression devices in responseto tension forces exerted on the strap retainers by the straps. In theillustrative embodiment depicted in connection with, e.g., FIG. 25, thetravel distance over which the strap retainer 801 can move relative tothe base 820 may, in one or more embodiments, be limited by the tensionindicator 803 to a selected travel distance.

In the depicted embodiment, the tension indicator 803 limits traveldistance to a selected travel distance through the use of a structuralstop 804 on the tension indicator 803. The structural stop 804 isconfigured to limit movement between the base 820 and the strap retainer801 to the selected travel distance through mechanical interferencebetween the slot 805 in which the tension indicator 803 moves and thestructural stop 804 on the tension indicator. In particular, thestructural stop 804 is of a size and/or shape that restricts movement ofthe structural stop 804 through the slot 805. As a result, after thestrap retainer 801 is moved away from the base 820 by the distancebetween the structural stop 804 and the strap retainer 801, furthermovement of the strap retainer 801 away from the base 820 is preventedbecause the structural stop 804 cannot pass through the slot 805.

The size and/or shape of the structural stop 804 and the slot 805 asseen in the illustrative embodiment depicted in FIG. 25 are only oneexample of structures that can provide mechanical interference to limittravel distance between a base and a strap retainer of a tissuecompression device as described herein.

Further, in one or more alternative embodiments, the distance betweenthe structural stop 804 and the fixed end 806 of the tension indicator803 (i.e., the end attached to the strap retainer 801) may be adjustedto change the selected tension force provided by the elastic member 802when the structural stop 804 reaches the slot 805 (or has its travelotherwise limited). Such an adjustment may be made by providing thestructural stop 804 in the form of a collar, plug, etc. that can bemoved to different locations along the tension indicator 803.

Furthermore, although the tension indicator 803 is described as having afixed end 806 attached to the strap retainer 801 and extending through aslot 805 in the base 820 of a tissue compression device 810, alternativeembodiments may involve a reverse configuration in which the fixed endof the tension indicator is attached to the base and extends through aslot or similar feature located within the strap retainer. In eithercase, the tension indicator can, in one or more embodiments, provideboth an indication of tension force exerted by the elastic memberextending between the strap retainer and the base, as well as,optionally, limiting travel distance as described herein.

In one or more embodiments of tissue compression devices as describedherein, the use of a tension indicator that limits travel distance to aselected travel distance may be advantageous. In particular, the limitedtravel distance may provide feedback to user that a selected tensionforce is being applied by the tissue compression device around a limb orother anatomical feature of a patient. With that baseline force beingset by the interactions between the strap and elastically attached strapretainer, adjustment of the pressure apparatus 840 associated with thetissue compression device 810 can and/or should be used to adjust thecompressive force being delivered to a selected location as describedherein.

Another illustrative embodiment of a strap retainer 901 attached to abase 920 of a tissue compression device is depicted in FIGS. 27-28 inboth a retracted position and an extended position. In particular, thestrap retainer 901 is in its retracted position with respect to base 920in FIG. 27, while the strap retainer 901 is in its extended position inFIG. 28. A comparison of these two figures shows that the strap retainer901 is located farther away from the base 920 when in the extendedconfiguration of FIG. 28 than when in the retracted configuration ofFIG. 27.

The strap retainer 901 is attached to the base 920 by an elastic member902. A tension indicator 903 extends through a slot 905 in the base 920,and the tension indicator 903 slides or moves through the slot 905 asthe strap retainer 901 moves between its retracted and extendedpositions.

In one or more embodiments, the tension indicator 903 may be providedwith one or more visible indicia 907 that indicate the position of thetension indicator 903 and, therefore, the position of the attached strapretainer 901, relative to the base 920 of a tissue compression device asdescribed herein. The visible indicia 907 on the tension indicator 903may be provided in a variety of different forms including, but notlimited to, shaded or colored areas, gradation marks, etc.

Disclosure of any patents, patent documents, and publications identifiedherein are incorporated by reference in their entirety as if each wereindividually incorporated. To the extent there is a conflict ordiscrepancy between this document and the disclosure in any suchincorporated document, this document will control.

Illustrative embodiments of the tissue compression devices or methodsare discussed herein some possible variations have been described. Theseand other variations and modifications in the invention will be apparentto those skilled in the art without departing from the scope of theinvention, and it should be understood that this invention is notlimited to the illustrative embodiments set forth herein. Accordingly,the invention is to be limited only by the claims provided below andequivalents thereof. It should also be understood that this inventionalso may be suitably practiced in the absence of any element notspecifically disclosed as necessary herein.

1-26. (canceled)
 27. A tissue compression device comprising: a base andretention structure attached to the base, the retention structureconfigured to retain the base over selected tissue at a selectedlocation; a bladder operably attached to the base, wherein a lowersurface of the bladder faces the selected tissue when the retentionstructure retains the base over the selected location, and wherein anupper surface of the bladder faces away from the lower surface of thebladder; a pressure indicator positioned on the upper surface of thebladder, wherein the pressure indicator comprises: a bellowed chambercomprising a top surface that is configured to move closer to the uppersurface of the bladder when pressure in the bladder is reduced andfarther away from the upper surface of the bladder when pressure in thebladder is increased, and an indicator housing, wherein the bellowedchamber is located in the indicator housing and visible through theindicator housing, wherein a position of the top surface of the bellowedchamber in the indicator housing is indicative of pressure in thebladder.
 28. A device according to claim 27, wherein the indicatorhousing comprises visible indicia arrayed along a side surface, whereinthe visible indicia is indicative of pressure in the bladder.
 29. Adevice according to claim 27, wherein the indicator housing is attachedto the upper surface of the bladder.
 30. A device according to claim 27,wherein the base comprises a bottom surface and a top surface, whereinthe base comprises a bladder orifice formed through the base from thebottom surface to the top surface, wherein the bellowed chamber and theindicator housing of the pressure indicator are located within aperimeter of the bladder orifice.
 31. A device according to claim 30,wherein the device defines a compression axis extending through theupper surface of the bladder, the bladder orifice in the base, and thelower surface of the bladder when the base is retained over the selectedlocation by the retention structure, and wherein the top surface of thebellowed chamber moves along the compression axis when pressure in thebladder is reduced or increased. 32-40. (canceled)
 41. A deviceaccording to claim 27, wherein an interior of the bellowed chamber is influid communication with an interior of the bladder through an openingin the upper surface of the bladder.
 42. A device according to claim 27,wherein the bladder includes a port connected to the bladder through achannel and configured to allow for fluid delivery into the bladder andfor fluid removal from the bladder.
 43. A device according to claim 27,wherein the indicator housing includes a vent allowing for the escape ofair from the indicator housing as the bellowed chamber expends whenpressure within the bladder increases.
 44. A device according to claim27, wherein the bladder includes an upper chamber positioned adjacent toa lower chamber.
 45. A device according to claim 44, wherein the bladderincludes an opening through which the upper chamber is in fluidcommunication with the lower chamber.
 46. A device according to claim44, wherein the upper chamber of the bladder is located above the topsurface of the base while the lower chamber of the bladder is locatedbelow the bottom surface of the base such that the lower chamber islocated between the base and the selected tissue.
 47. A device accordingto claim 44, wherein a connection between the upper chamber of thebladder and the lower chamber of the bladder is located within a bladderorifice formed in the base.